Legend Biotech Reports Strong First Quarter 2025 Performance and Strategic Milestones as CARVYKTI® Continues to Lead in Multiple Myeloma
Legend Biotech Corporation, a global frontrunner in the field of cell therapy, has reported its financial results for the first quarter of 2025, along with a series of key regulatory, clinical, and operational milestones that further position the company for sustainable growth and profitability. With continued commercial momentum for CARVYKTI®, the company’s flagship CAR-T therapy, Legend Biotech is advancing toward long-term financial independence while expanding its global footprint in cell-based treatments for hematologic malignancies.
CARVYKTI® Continues to Define the Standard in CAR-T Therapy for Multiple Myeloma
In a statement accompanying the earnings report, Dr. Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech, emphasized the growing impact of CARVYKTI®, which has shown sustained commercial success and clinical relevance.
“CARVYKTI, underpinned by its continued strong commercial performance, continues to set the standard for CAR-T therapies in multiple myeloma,” said Dr. Huang. “We believe our achievements from this past quarter, including capacity expansion and additional global approvals, are setting the stage for Legend Biotech to achieve company-wide profitability by next year.”
CARVYKTI®, also known as ciltacabtagene autoleucel (cilta-cel), is a BCMA-directed, genetically modified autologous T-cell immunotherapy co-developed with Janssen Biotech, Inc. The therapy has been approved across multiple geographies and continues to expand its regulatory and commercial footprint.
Global Regulatory Advancements Cement CARVYKTI’s Global Reach
The first quarter of 2025 was marked by significant progress in securing new regulatory endorsements for CARVYKTI®, solidifying its standing as a global leader in CAR-T innovation:
- European Union: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion regarding the CARTITUDE-4 trial update for CARVYKTI®. This pivotal trial demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) for patients with multiple myeloma. The regulatory body also agreed to update CARVYKTI’s Summary of Product Characteristics to reflect new data on progression-free survival (PFS), OS, and safety, based on a second interim analysis.
- Australia: The Therapeutic Goods Administration (TGA) approved the registration of CARVYKTI® for use in adult patients with relapsed or refractory multiple myeloma. The approval applies to two groups: patients who have received at least one prior therapy (including an immunomodulatory drug and a proteasome inhibitor) and are refractory to lenalidomide, and patients who have undergone at least three prior lines of therapy that include a PI, an IMiD, and an anti-CD38 antibody.
These developments reinforce Legend Biotech’s strategy of building a robust regulatory foundation across continents, thereby enabling broader access to its transformative cell therapies.
Expanding Manufacturing Capacity to Meet Surging Global Demand
With increasing demand for CARVYKTI® driven by global market penetration, Legend Biotech continues to invest in manufacturing infrastructure:
- European Expansion: In Q1 2025, the company initiated clinical production of CARVYKTI® at its Tech Lane facility in Ghent, Belgium. Commercial production at this site is expected to begin before the end of the year. Once operational at full capacity, the facility will enhance global manufacturing capabilities and mitigate bottlenecks in the supply chain—crucial for ensuring timely delivery of CAR-T therapies to patients worldwide.
- Clinical Milestone: To date, more than 6,000 patients have been treated with CARVYKTI® across clinical and commercial settings, highlighting both the therapy’s uptake and its potential to reshape treatment paradigms in multiple myeloma.
ESG Commitments and Long-Term Sustainability
Legend Biotech also published its second annual Environmental, Social, and Governance (ESG) report, which reflects the company’s commitment to corporate responsibility and ethical growth. The report, based on fiscal year 2024 data, aligns with key reporting frameworks including:
- The Sustainable Accounting Standards Board (SASB) for the Biotechnology and Pharmaceutical sector
- The Greenhouse Gas (GHG) Protocol
- Select standards from the Global Reporting Initiative (GRI)
This report underscores Legend’s prioritization of sustainability and ethical practices, affirming its commitment to the well-being of patients, employees, and global communities.
Financial Results for the First Quarter of 2025
Legend Biotech closed the first quarter of 2025 with a solid financial position, driven largely by rising collaboration revenue from CARVYKTI® sales under its partnership with Janssen.
Cash Position
- The company held $1.0 billion in cash, cash equivalents, and time deposits as of March 31, 2025.
- This strong liquidity position is expected to sustain operations through the second quarter of 2026, by which point the company aims to achieve operating profitability—excluding the impact of unrealized foreign exchange fluctuations.
Revenue Performance
- License Revenue: Legend reported $9.3 million in license revenue for Q1 2025, compared to $12.2 million in Q1 2024. The decline is attributable to timing-related factors under the company’s license agreement with Novartis, covering the development of LB2102 and other CAR-T candidates targeting DLL-3.
- Collaboration Revenue: Revenue from collaboration activities surged to $185.6 million, a significant increase from $78.5 million in Q1 2024. This jump was largely due to continued growth in CARVYKTI® sales, executed in collaboration with Janssen Biotech.
Expense Breakdown
- Cost of Collaboration Revenue: This cost rose to $69.5 million, compared to $49.1 million in the prior-year quarter. The increase reflects higher production costs and Legend’s share of commercial sales under the Janssen partnership.
- Cost of License and Other Revenue: Expenses in this category decreased to $1.8 million from $5.6 million in Q1 2024, reflecting reduced activity under the Novartis License Agreement.
- Research and Development (R&D): R&D expenses were relatively stable at $101.9 million, compared to $101.0 million last year. Ongoing trials of cilta-cel in the frontline setting were offset by a reduction in other R&D programs tied to cilta-cel.
- Administrative Expenses: Administrative spending remained steady at $31.5 million, showing little change from $31.9 million in Q1 2024. Increases in staffing-related expenses due to hiring were balanced by decreased IT expenditures.
- Selling and Distribution Expenses: These costs increased significantly to $41.0 million, from $24.2 million a year earlier. The rise was linked to expanded commercial activity and scaling of the salesforce amid accelerating CARVYKTI® adoption.
Net and Adjusted Losses
- Net Loss: Legend Biotech posted a net loss of $100.9 million, up from $59.8 million in the year-ago quarter. The increased loss reflects higher operational investments needed to support commercial growth and infrastructure buildout.
- Adjusted Net Loss: However, the adjusted net loss narrowed considerably to $27.0 million, a sharp improvement from $85.3 million in Q1 2024. This improvement suggests better operational efficiency and revenue leverage, laying the foundation for future profitability.
Positioned for Profitability and Continued Growth
Legend Biotech is focused on three strategic imperatives: global expansion of CARVYKTI®, pipeline advancement, and long-term financial sustainability. The company’s expanding manufacturing capabilities, robust cash reserves, and growing commercial footprint support its vision of becoming a fully integrated, profitable biotechnology company by 2026.
With a promising regulatory trajectory, increased global access to its lead CAR-T therapy, and a disciplined approach to capital deployment, Legend Biotech is poised to remain a leader in the fast-evolving field of cell therapy.
